483
Lawrence Werlin MD, Inc. dba Coastal Fertility Medical CenterFDA 483 - Lawrence Werlin MD, Inc. dba Coastal Fertility Medical Center - January 09, 2026
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
An FDA inspection of Lawrence Werlin MD, Inc. dba Coastal Fertility Medical Center in Irvine, CA, identified two observations. The firm failed to adequately screen oocyte donors for communicable disease risk factors and did not properly label Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from donors with incomplete screening. These issues indicate deficiencies in donor eligibility determination and product control.
- Inspection Date
- January 9, 2026
- Product Type
- Biologics
Open in Dashboard
ID · c6a69399-d35c-4a09-9b54-7ace39175eb9